Integrated fluidic chip for transdermal sensing of physiological markers

Abstract

The present invention is directed to devices and methods for detecting one or more markers in a sample. In particular, such devices integrate a plurality of hollow needles configured to extract or obtain a fluid sample from a subject, as well as transducers to detect a marker of interest (e.g., an electrolyte). In some embodiments, the needles are provided as a disposable cartridge.

1 . A multilayered device for detecting one or more markers in a sample comprising:
 an array comprising a plurality of hollow needles and a substrate coupled to the plurality of hollow needles, wherein each of the plurality of hollow needles has an interior surface facing a hollow lumen and an exterior surface, a distal end of the exterior surface for at least one needle comprises a puncturing edge, and at least one of the plurality of hollow needles has a length of more than about 0.5 mm; and wherein the substrate comprises an inlet in fluidic communication with a proximal end of at least one of the plurality of hollow needles;   a first layer comprising an aperture configured to include the array;   a second layer comprising a first chamber configured to be in fluidic communication with the inlet of the substrate and a first channel in fluidic communication with the first chamber, wherein the second layer is disposed below the first layer; and   a third layer comprising a port configured to place a sensing transducer in fluidic communication with the first channel, wherein the sensing transducer is configured to detect said one or more markers in the sample and wherein the third layer is disposed below the second layer.   
     
     
         2 . The device of  claim 1 , further comprising a mixing chamber in fluidic communication with the first channel. 
     
     
         3 . The device of  claim 2 , further comprising a reaction chamber in fluidic communication with the mixing chamber. 
     
     
         4 . The device of  claim 2 , further comprising a reagent chamber in fluidic communication with the mixing chamber. 
     
     
         5 . The device of  claim 1 , wherein the plurality of hollow needles is configured to obtain the sample from a subject. 
     
     
         6 . The device of  claim 5 , wherein the puncturing edge of one or more of the plurality of hollow needles comprises a tapered point, a sharpened bevel, or one or more prongs. 
     
     
         7 . The device of  claim 1 , wherein at least one of the plurality of hollow needles comprises a polymer, a metal, silicon, glass, or a composite material. 
     
     
         8 . The device of  claim 1 , wherein the sensing transducer is selected from the group consisting of an electrode, an ion selective electrode, and an optical sensor. 
     
     
         9 . The device of  claim 8 , wherein the sensing transducer is an ion selective electrode comprising a porous material and one or more ionophores. 
     
     
         10 . The device of  claim 8 , wherein the sensing transducer further comprises a modified surface. 
     
     
         11 . The device of  claim 10 , wherein the sensing transducer comprises an array of electrodes. 
     
     
         12 . The device of  claim 8 , wherein the sensing transducer is an electrode selected from the group of a planar electrode, a three-dimensional electrode, a porous electrode, a microelectrode, and a nanoelectrode. 
     
     
         13 .- 15 . (canceled) 
     
     
         16 . The device of  claim 1 , wherein the plurality of hollow needles and the substrate are configured as a disposable cartridge module. 
     
     
         17 . The device of  claim 16 , wherein the disposable cartridge module comprises:
 a barrel comprising an internal volume, a distal end, and a proximal end, wherein the distal end of the barrel is coupled to the plurality of hollow needles and the substrate and the proximal end of the barrel comprises an opening.   
     
     
         18 .- 19 . (canceled) 
     
     
         20 . A kit comprising:
 a device of  claim 1 ; and   (ii) instructions for affixing the device to a subject and activating the device.   
     
     
         21 . The kit of  claim 20 , further comprising a therapeutic agent selected from the group consisting of an anesthetic, an antiseptic, an anticoagulant, a drug, and a vaccine. 
     
     
         22 .- 29 . (canceled) 
     
     
         30 . A platform comprising a disposable cartridge module and a handheld module,
 wherein the disposable cartridge module comprises:
 an array comprising a plurality of hollow needles and a substrate coupled to the plurality of hollow needles, wherein each of the plurality of hollow needles has an interior surface facing a hollow lumen and an exterior surface, a distal end of the exterior surface for at least one needle comprises a puncturing edge, and at least one needle has a length of more than about 0.5 mm; and wherein the substrate comprises an inlet in fluidic communication with a proximal end of at least one of the plurality of hollow needles; 
 a first layer comprising an aperture configured to include the array; 
 a barrel comprising an internal volume, a surface portion defining the internal volume, a distal end, and a proximal end, wherein the distal end of the barrel is coupled to the plurality of hollow needles and the substrate, or a portion thereof, and the proximal end of the barrel comprises an opening; and 
 a ridge disposed on the surface portion of the barrel; and 
   wherein the handheld module comprises:
 a body, wherein the body comprises a distal section and a proximal section; 
 a central bore disposed within the body and in fluidic communication with the disposable cartridge module; 
 a mounting shaft disposed on the distal section of the body, wherein the mounting shaft is configured to be inserted into the opening of the disposable cartridge module; and 
 a stop member structure disposed on an outer surface portion of the mounting shaft, wherein the stop member structure is configured to interface with the ridge of the disposable cartridge module. 
   
     
     
         31 . The platform of  claim 30 , wherein the body further comprises a sensing transducer in fluidic communication with the internal volume, and wherein the sensing transducer is configured to detect one or more markers in the sample. 
     
     
         32 . The platform of  claim 30 , wherein the body further comprises a pump configured to transport the sample from the plurality of hollow needles and/or the internal volume into the central bore. 
     
     
         33 . The platform of  claim 30 , wherein the handheld module further comprises an electronic readout interface configured to wirelessly communicate with the handheld module, and wherein the electronic readout interface is selected from the group consisting of a smartphone, a cell phone, a mobile device, or a mobile phone. 
     
     
         34 . The platform of  claim 30 , further comprising a chamber in fluidic communication with the disposable sample module and/or the central bore of the handheld module. 
     
     
         35 .- 37 . (canceled) 
     
     
         38 . The device of  claim 1 , further comprising:
 a fourth layer comprising a plurality of accesses in fluidic communication with the port, wherein the fourth layer is disposed below the third layer.   
     
     
         39 . The device of  claim 38 , further comprising:
 a base layer comprising a plurality of further accesses in fluidic communication with the plurality of accesses in the fourth layer, wherein the base layer is disposed below the fourth layer.   
     
     
         40 . The device of  claim 39 , further comprising one or more wiring, electrodes, or fluidic connections inserted into at least one of the plurality of further accesses in the base layer. 
     
     
         41 . A platform comprising:
 a disposable cartridge comprising the multilayered device of  claim 1 ; and   a handheld module comprising a body and a central bore configured to be in fluidic communication with the disposable cartridge.   
     
     
         42 . The platform of  claim 41 , wherein a distal portion of the body comprises a mounting shaft configured to interface with the disposable cartridge, and wherein a proximal portion of the body includes a handle. 
     
     
         43 . The platform of  claim 42 , wherein body further comprises a release lever configured to detach the disposable cartridge from the handheld module. 
     
     
         44 . The platform of  claim 42 , wherein the body is configured to interface with an electronic readout interface, and wherein the electronic readout interface is selected from the group consisting of a smartphone, a cell phone, a mobile device, or a mobile phone. 
     
     
         45 . The platform of  claim 30 , wherein the disposable cartridge module further comprises an o-ring disposed on the surface portion of the barrel. 
     
     
         46 . The device of  claim 1 , further comprising a reaction chamber in fluidic communication with the first channel. 
     
     
         47 . The device of  claim 46 , further comprising a mixing chamber in fluidic communication with the reaction chamber. 
     
     
         48 . The device of  claim 46 , further comprising a reagent chamber in fluidic communication with the reaction chamber. 
     
     
         49 . The device of  claim 9 , wherein the porous material comprises porous carbon, graphene, silicon, or conducting polymer. 
     
     
         50 . The device of  claim 11 , wherein the array of electrodes comprises immobilized capture antibodies.